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510(k) Data Aggregation
(28 days)
Biomet 3i, LLC
The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672.
The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.
The provided FDA 510(k) clearance letter and associated documentation for the "T3 Pro Implants- ZimVie Packaging System" (K251660) do not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.
Instead, this submission is for a medical device (endosseous dental implant) and its new packaging system. The "performance data" section explicitly states that no clinical data was included in the submission for the substantial equivalence determination. The focus of the provided document is to demonstrate equivalence to a previously cleared predicate device for the dental implant itself, with the primary change being the packaging system.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance related to an AI-assisted or standalone AI system, nor can I provide details on sample size, expert adjudication, MRMC studies, or ground truth establishment, as these concepts are not discussed or relevant to the provided documentation for this specific 510(k) clearance.
The information provided describes non-clinical performance data related to the physical device and its packaging:
- Sterilization validation: Gamma irradiation sterilization to a sterility assurance level of 10^-6 according to ISO 13004 and ISO 11137.
- Aging studies: Demonstrating a shelf life of two (2) years for the implants, with packaging sterile barrier testing per ASTM F1980.
- Packaging studies: Simulated distribution and environmental conditioning per ISTA 3A and ASTM D4169.
- Biological evaluation: Leveraged from the primary predicate device, demonstrating no increased risks regarding biocompatibility. The material is Commercially Pure Titanium conforming to ASTM F67.
- MR Safety testing: Conducted according to ASTM F2503-13 on the primary predicate device (identical to the subject device) for MR Conditional determination.
- Bacterial Endotoxin Testing: Routinely performed using LAL assay in accordance with ISO 11737-3.
The acceptance criteria for this submission would primarily revolve around demonstrating that the new packaging system maintains the sterility, integrity, and safety of the dental implant for its stated shelf life, and that the dental implant itself remains identical to the previously cleared predicate device in all other aspects (materials, design, intended use, operating principle).
In summary, your request pertains to an AI/Software as a Medical Device (SaMD) study, while the provided document describes the 510(k) clearance process for a physical dental implant device and its new packaging.
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(127 days)
Biomet 3i, LLC
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured by | ||
| Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by | ||
| Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
The provided text is a 510(k) summary for a medical device (Immediate Molar Implants) and does not contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.
The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, non-clinical testing (fatigue, MR compatibility, pull-out tests, surface area analysis, sterilization, biocompatibility, shelf life), and contractual agreements for compatible components.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using clinical or performance data, as this information is not present in the provided text. The document describes a dental implant, not an AI or software-based device that would typically have acceptance criteria presented in the manner requested.
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(90 days)
Biomet 3i, LLC
The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments.
All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture.
The BellaTek Bars are indicated for compatibility with the following abutment systems:
· Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees
- · ZimVie Eztetic Implant System
- · ZimVie TSX Implant System
- · ZimVie Tapered Screw-Vent System
- · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees
- · ZimVie Osseotite Implant System
- ZimVie T3 and T3 PRO Implant System
- · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees
- · ZimVie TSX Implant System
- · ZimVie Tapered Screw-Vent Implant System .
The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag.
Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices.
The BellaTek Bars are dental implant abutments intended to restore chewing function in partially or fully edentulous jaws by attaching to a minimum of two abutments.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are primarily aligned with demonstrating substantial equivalence to a predicate device through materials, design specifications, and performance bench testing. Specific quantitative performance targets are not explicitly listed in an "acceptance criteria" table format in the provided document, but rather implied through comparison to existing standards and predicate devices.
| Acceptance Criteria Category | Description and Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to the primary predicate device (K233083). |
| – BellaTek Bars: Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Biomet 3i. | |
| – Predicate Device (Osteon Precision Milled Suprastructure K233083): Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Osteon. | |
| Design Principles & Technological Characteristics | Substantially equivalent to the primary predicate device (K233083) and reference predicate device (K080864). |
| - Similar features: bar base material, bar-to-abutment connection, prosthetic platform sizes, mode of prosthetic retention. | |
| - Differences in prosthetic platform connection geometry are supported by identified predicate devices. | |
| Material and Manufacturing | Bar Material: Ti-6Al-4V ELI (ASTM F136) or Grade 4 CP Titanium (ASTM F67). |
| - Meets chemical and mechanical requirements of ASTM F136 and ASTM F67. | |
| - Packaging: Nylon pouch. | |
| - Sterilization Process: Moist heat, validated according to EN ISO 17665-1:2006 to achieve a sterility assurance level (SAL) of 10-6. | |
| Biocompatibility | Testing performed according to ISO 10993-1:2018 and ISO 10993-5:2009 on representative Biomet 3i patient-specific bar devices using the same ASTM F136 titanium alloy and ASTM F67 unalloyed titanium materials. |
| - Concluded that the material, chemical testing, and literature provide sufficient basis for demonstrating biocompatibility. | |
| MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). |
| - Addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. | |
| - Reported Performance: BellaTek Bars have been labeled as MR conditional. | |
| Performance Bench Testing | Worst-case design validated in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004. |
| - Demonstrates that differences from the predicate are accounted for and do not render the device not substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. The document refers to "worst case design" being validated. For sterilization, the validation process implies testing units to demonstrate SAL. For biocompatibility, "representative Biomet 3i patient-specific bar devices" were used. For MRI review, it was a "non-clinical worst-case MRI review... based on the entire system including all variations." This suggests a methodology of evaluating design limits and material properties rather than a large clinical test set.
- Data Provenance: The studies are non-clinical (bench testing, material analysis, literature review, MRI rationale). No specific country of origin for non-clinical data is mentioned, but the standards followed (e.g., ASTM, ISO, EN ISO) are international. The studies are by nature prospective as they are conducted to support the specific device submission, but they leverage established scientific literature and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the studies are non-clinical bench tests, material characterizations, and literature reviews, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense does not directly apply. The "ground truth" for these types of studies is established by:
- Regulatory Standards: Adherence to recognized standards like ASTM F136, ASTM F67, ISO 10993-1, ISO 10993-5, EN ISO 17665-1, and FDA guidance documents.
- Engineering and Scientific Expertise: The performance of bench tests, material analysis, and MRI safety assessments would be conducted by engineers, material scientists, and physicists with expertise in these areas. While individual names or specific numbers aren't listed, this expertise is inherent in conducting such tests.
- Literature: The MRI safety assessment explicitly mentions using "published literature" as part of its scientific rationale, implying leveraging the consensus of experts in that field.
No specific number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") are provided in the context of establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies where subjective interpretation is involved (e.g., image reading). The studies described here are non-clinical, objective evaluations (bench testing, material analysis).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No. The provided document states: "No clinical data were included in this submission." Therefore, no MRMC study or AI assistance evaluation was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental implant bar, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Regulatory Standards and Specifications: Adherence to performance parameters detailed in FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"), and international standards (ASTM, ISO, EN ISO).
- Material Properties: Data derived from chemical and mechanical testing of the materials (ASTM F136, ASTM F67).
- Biocompatibility Endpoints: Established biological safety endpoints defined by ISO 10993 standards.
- MRI Safety Rationale: Scientific principles and published literature related to magnetic fields and medical devices.
- Demonstration of Substantial Equivalence: Direct comparison of technological characteristics and performance to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed through traditional engineering methods and validated through the testing described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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(163 days)
Biomet 3i LLC
The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.
For specific product descriptions, please refer to individual product labels.
The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.
The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.
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(126 days)
Biomet 3i LLC
The T3 Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
The T3 Pro Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the T3 Pro Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy.
The provided document is a 510(k) summary for a medical device (T3 Pro Implants) and does not contain information regarding software or AI performance.
Therefore, I cannot provide an answer addressing the acceptance criteria and study proving device performance for AI/software, as the document does not pertain to such a device.
The document discusses the substantial equivalence of the T3 Pro Implants to predicate devices based on non-clinical testing rather than AI/software performance evaluations.
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(113 days)
Biomet 3i LLC
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.
This document is a 510(k) Premarket Notification from the FDA regarding the "BellaTek Encode Emergence Healing Abutments". It does not describe an AI/ML device, therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not present.
The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than an AI/ML device's performance.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The device is a physical dental implant component (healing abutment), not a software algorithm or AI-powered system.
- Substantial Equivalence: The approval process here is based on showing that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific performance metrics for an AI algorithm.
- Non-Clinical Testing: The "Non-Clinical Testing" section describes tests related to physical properties, biocompatibility, sterilization, and shelf-life, which are typical for physical medical devices. It does not mention any studies related to AI/ML performance metrics like accuracy, sensitivity, specificity, etc.
Therefore, since the input document describes a physical medical device and not an AI/ML device, it does not contain the information requested in the prompt about AI/ML acceptance criteria and study details.
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(87 days)
Biomet 3i LLC
TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.
The provided document is a 510(k) summary for a medical device (dental abutments) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance of an AI/algorithm-based device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, function, materials, indications for use, and non-clinical testing.
Here's a breakdown of the available information relevant to product acceptance, though it's for a physical medical device, not an algorithm:
1. A table of acceptance criteria and the reported device performance:
The document primarily demonstrates substantial equivalence through comparisons with predicate devices and adherence to relevant standards. It doesn't present a table of specific performance acceptance criteria in the way one would for an AI model's metrics (e.g., sensitivity, specificity).
Instead, "performance" here refers to the physical and biological characteristics of the dental abutment and its components:
| Characteristic/Test | Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Sterilization Validation (Steam) | Conformance to ISO 17665-1 | Successfully validated (SAL of 10^-6) |
| Sterilization Validation (Gamma) | Conformance to ISO 11137-1 and ISO 11137-2 | Successfully validated (SAL of 10^-6, 25-38 kGv exposure dose, VDmax35 method) |
| Biocompatibility | Conformance to ISO 10993-1 | Acceptable biocompatibility demonstrated by reference to predicate device K183138 |
| Magnetic Resonance (MR) Conditional | Demonstrated as MR Conditional | Demonstrated as MR Conditional by reference to K150571 |
| Aging/Shelf-Life (Abutment) | Not applicable (supplied non-sterile) | N/A |
| Aging/Shelf-Life (Retaining Screw) | 5-year shelf-life | Maintaining a 5-year shelf-life |
| Packaging Integrity (Retaining Screw) | Withstand shipping/vibration; maintain sterile barrier; meet dye penetration & seal strength criteria (ISO 11607-1) | Met acceptance criteria for dye penetration and seal strength after accelerated and real-time aging, and shipping/distribution tests. |
| Material (Abutment) | Titanium Alloy (Ti-6Al-4V ELI) and Zirconia | Titanium Alloy (Ti-6Al-4V ELI) and Zirconia |
| Material (Retaining Screw) | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy (Ti-6Al-4V ELI) |
| Design/Function/Intended Use | Substantially equivalent to predicate devices | Aligned with predicate devices K183138 and K133551 |
Regarding the other points you requested (2 through 9), they are not applicable as this document discusses a physical medical device, not an AI/algorithm:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device. The "tests" mentioned are non-clinical (e.g., sterilization, biocompatibility, packaging), not an evaluation of an algorithm on a dataset.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth, in the context of expert review, is not relevant to the non-clinical testing performed for dental abutments.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document explicitly states, "No clinical data was included in this submission."
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device's performance relies on adherence to material specifications, engineering standards, and biological compatibility.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a physical medical device, not an AI or algorithm. Therefore, the specific details you requested regarding AI model evaluation are not present.
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(231 days)
Biomet 3i
Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
This document pertains to the 510(k) premarket notification for Certain BellaTek® Express and BellaTek® Flex Abutments, K183138. It describes dental implant abutments and does NOT describe an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be extracted from this document.
The document discusses substantial equivalence to predicate devices based on:
- Intended Use: Similar, supporting prosthetic devices in edentulous patients.
- Operating Principle: Attaching to dental implants to restore chewing function.
- Identical Materials: Titanium Alloy (Ti-6Al-4V ELI) and Zirconia for abutments.
- Similar Fundamental Design: Including platform diameters, screw or cement retention options.
Performance Data (Non-clinical):
- Sterilization Validation: Per FDA Guidance and ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10^-6.
- Biological Evaluation: In accordance with FDA Guidance and ISO 10993-1, demonstrating acceptable biocompatibility.
- MR Testing Data: Leveraged, and the device is labeled as MR conditional.
- Design & Development: In accordance with FDA Guidance Document for Root-form Endosseous Dental Implants and Abutments.
No clinical data was included in this submission.
Therefore, I cannot provide the information requested in the format of an AI/ML device acceptance criteria and study.
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(47 days)
Biomet 3i
The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.
TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.
The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (TSV™ BellaTek® Encode® Healing Abutments) demonstrating substantial equivalence to a predicate device.
The document explicitly states: "No clinical data were included in this submission." and relies on non-clinical testing data and equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.
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BIOMET 3I
The Eztetic™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method.
This document, a 510(k) summary for the Eztetic™ BellaTek® Encode® Healing Abutments, describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as these are typically associated with clinical performance studies, which are not detailed in this document.
However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence:
Non-Clinical Testing Information:
Since this is a non-clinical evaluation for substantial equivalence, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not directly applicable in the way they would be for a clinical efficacy or safety study.
Instead, the document describes tests conducted to ensure the new device is comparable to existing, legally marketed devices.
Here's a breakdown of the non-clinical testing mentioned:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence):
| Non-Clinical Test / Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Performance (Implied by Conclusion of Substantial Equivalence) |
|---|---|---|
| MR Compatibility | Device is MR conditional (same as previously tested Biomet 3i devices). | The subject devices, having less surface area and volume and made of identical materials as previously tested MR-compatible Biomet 3i devices, are considered MR conditional. |
| Biocompatibility | Biologically compatible (same as primary predicate devices). | The subject devices, made of identical materials and manufactured under identical conditions as primary predicate devices, leverage the predicate's biocompatibility data. |
| Sterilization Efficacy | Minimum Sterility Assurance Level (SAL) of 10⁻⁶; compliance with ISO 11137-1 and ISO 11137-2. | Sterilization validated at 25-38 kGy using gamma irradiation, achieving a SAL of 10⁻⁶, consistent with ISO standards. Quarterly dose audits are conducted. |
| Shelf-Life | Maintain structural integrity and performance for 5 years. | Substantiated 5-year shelf-life based on material stability (Ti-6Al-4V ELI) and successful accelerated/real-time aging studies of packaging. |
| Packaging Integrity | Maintain sterile barrier over labeled shelf life; withstand shipping/vibration conditions without compromise to sterility. | Met acceptance criteria for dye penetration and seal strength after accelerated/real-time aging and shipping/distribution testing (per ISO 11607-1, ASTM D4169). |
| Torque to Failure | Withstand recommended torque (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific values not provided, but passed). |
| Physical Fit Check | Device fits correctly with the mating implant (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Tolerance Analysis | Entire tolerance range meets design input (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Print Verification | Properly constrained and accurately describes intended original design (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: The data is primarily derived from "leveraged" data from previously tested Biomet 3i devices and predicate devices, as well as new bench testing. There is no mention of country of origin as it's non-clinical lab testing. All testing appears to be prospective in the sense that the tests were conducted for this submission, although some rely on retrospective leveraging of prior data.
3. Number of Experts and Qualifications (for Ground Truth):
- This concept is not directly applicable to the non-clinical tests described. The "ground truth" here is adherence to engineering specifications, material properties, and regulatory standards, evaluated by qualified personnel within the company and verified by regulatory bodies.
4. Adjudication Method for Test Set:
- Not applicable as these are non-clinical engineering and material tests, not expert-adjudicated clinical data.
5. MRMC Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The device in question is a physical dental healing abutment, not an AI diagnostic tool.
6. Standalone Study (Algorithm Only Without Human-in-the-Loop Performance):
- No, a standalone study in this context (algorithm performance) was not done as the device is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the physical and material characteristics themselves, which are addressed by the non-clinical bench testing.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is based on:
- Regulatory Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F 136.
- Engineering Specifications: Design inputs, tolerance ranges, recommended torque values.
- Material Science Properties: Known characteristics of Ti-6Al-4V ELI.
- Prior Validated Test Data: From predicate and previously tested Biomet 3i devices (e.g., for MR compatibility, biocompatibility).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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